MP1032 Treatment in Patients With Moderate to Severe COVID-19
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MP1032 with standard of care (SoC) verses placebo with SoC in hospitalized adults participants with moderate to severe coronavirus disease 2019 (COVID-19).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MP1032 Participants will receive MP1032 300 milligrams (mg) twice daily (BID) with hospital selected SoC for 28 days. |
Drug: MP1032
Hard gelatin capsules for oral administration.
|
| Placebo Comparator: Placebo Participants will receive placebo matched to MP1032 with hospital selected SoC for 28 days. |
Drug: Placebo
Placebo capsules matched to MP1032 for oral administration.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants with Disease Progression at Day 14 [Day 14]
The National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale is an assessment of clinical status on a given study day and is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or extracorporeal membrane oxygenation [ECMO]) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities Disease progression defined as participants who are not alive or who have respiratory failure (participants who have a score of 2, 3, or 4 on the NIAID scale).
Secondary Outcome Measures
- Percentage of Participants with Disease Progression at Day 28 [Day 28]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities Disease progression is defined as participants who are not alive or who have respiratory failure (participants who have a score of 2, 3, or 4 on the NIAID 8-point ordinal scale).
- Percentage of Participants with Disease Resolution at Day 28 [Day 28]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities Disease resolution is defined as participants who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale.
- All-cause Mortality Rate at Day 28 [Day 28]
- Change from Baseline in Clinical Status related to COVID-19 according to the NIAID 8-point Ordinal Scale at Day 28 [Baseline, Day 28]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities
- Percentage of Participants with Disease Resolution at Day 14 [Day 14]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities Disease resolution is defined as participants who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale.
- All-cause Mortality Rate at Day 14 and Day 60 [Day 14 and Day 60]
- Change from Baseline in Clinical Status related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14 [Baseline, Day 14]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities
- Percentage of Participants requiring Invasive Ventilation (Mechanical Ventilator and/or ECMO), or who are not Alive on Day 14 and Day 28 [Day 14 and Day 28]
- Percentage of Participants in each category of the NIAID 8-point Ordinal Scale [From Baseline up to Day 60]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities
- Time to (First) Improvement of at least 1 Category on the NIAID 8-point Ordinal Scale [From Baseline up to Day 28]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities
- The Odds Ratio for the Number of Participants with Clinical Status Improvement From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 [Baseline, Day 14 and Day 28]
The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale is defined as follows; where higher score indicates improvement in the clinical status: Death Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons) Not hospitalized, limitation on activities, and/or requiring home oxygen Not hospitalized, no limitations on activities
- Total Duration of Hospitalization at Day 28 and Day 60 [From Baseline, Day 28 and Day 60]
- Percentage of Participants alive and testing negative for COVID-19 at Day 14, Day 28, and Day 60 [Day 14, Day 28 and Day 60]
- Number of Participants with treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Day 1 up to Day 60]
- Number of Participants with Vital Sign Abnormalities [Day 1 up to Day 60]
Systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature) abnormalities will be reported.
- Number of Participants With Physical Examination Findings [Day 1 up to Day 60]
- Number of Participants with Laboratory Findings [Day 1 up to Day 60]
Abnormalities in haematology, coagulation, clinical chemistry, serum inflammatory, and urinalysis abnormalities will be reported.
- Maximum Observed Plasma Concentration (Cmax) of MP1032 [Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7]
- Area Under the Plasma Concentration-time curve from Time Zero (pre-dose) to last non-zero concentration (AUC0-t) of MP1032 [Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7]
- Apparent Elimination Rate Constant (K) of MP1032 [Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7]
- Apparent Body Clearance (CL) of MP1032 [Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7]
- Apparent Volume of Distribution (Vd) of MP1032 [Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7]
- Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 [Pre-dose at Day 1 and Day 7]
- Average Observed Plasma Concentration at Steady State of MP1032 [Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 7]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Participant is admitted to hospital and has a positive severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) test by standard reverse transcription-polymerase chain reaction (RT-PCR) assay or equivalent test
-
Participant has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19
Key Exclusion Criteria:
-
Participant, in opinion of the investigator, is not likely to survive >=48 hours beyond Day 1
-
Participant has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1
-
Participant has a documented medical history of infection with hepatitis A, B, C, or with human immunodeficiency virus (with a detectable viral load and CD4 count <500 cells per micro liter), or a documented active infection with tuberculosis.
-
The Participant has clinically significant electrocardiogram (ECG) abnormalities at screening
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Snake River Research PLLC | Idaho Falls | Idaho | United States | 83404 |
| 2 | Richmond University Medical Center | Staten Island | New York | United States | 10310 |
| 3 | MHAT Dr. Stamen Iliev AD | Montana | Bulgaria | ||
| 4 | SHATPD Pernik EOOD | Pernik | Bulgaria | ||
| 5 | "Second Multiprofile Hospital For Active Treatment - Sofia" Ead | Sofia | Bulgaria | ||
| 6 | Umhatem"N.I.Pirogov" | Sofia | Bulgaria | ||
| 7 | SHATPPD Sata Zagora EOOD | Stara Zagora | Bulgaria | ||
| 8 | Centre Hospitalier Victor Dupouy | Argenteuil | France | ||
| 9 | CHU de Grenoble Alpes | Grenoble Cedex 9 | France | ||
| 10 | Centre Hospitalier Lyon Sud | Pierre-Benite CEDEX | France | ||
| 11 | DE KK Infektológiai Klinika | Debrecen | Hungary | ||
| 12 | Flor Ferenc Hospital of Pest County | Kistarcsa | Hungary | ||
| 13 | IRCCS Ospedale San Raffaele | Milan | Italy | ||
| 14 | Polo Universitario - L'Azienda Ospedaliera Luigi Sacco | Milan | Italy | ||
| 15 | Policlinico Agostino Gemelli | Roma | Italy | ||
| 16 | Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes" | Bucharest | Romania | ||
| 17 | Spitalul Municipal Caracal | Caracal | Romania | ||
| 18 | Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" | Iaşi | Romania | ||
| 19 | Spitalul Judetean de Urgenta "Sfantul Ioan cel Nou" | Suceava | Romania | ||
| 20 | Clinica Anestezie si Terapie Intensiva | Timişoara | Romania | ||
| 21 | Hospital Clinic de Barcelona Hospital Clinic i Provincial | Barcelona | Spain | ||
| 22 | Hospital Ramon y Cajal, Edificio Central | Madrid | Spain | ||
| 23 | Hospital Clínico Universitario de Salamanca | Salamanca | Spain | ||
| 24 | Hospital Universitario Marqués de Valdecilla/IDIVAL | Santander | Spain | ||
| 25 | Hospital Universitario de Valme | Sevilla | Spain | ||
| 26 | Hospital Álvaro Cunqueiro | Vigo | Spain |
Sponsors and Collaborators
- MetrioPharm AG
- Syneos Health, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MP1032-CT05
- 2021-000344-21